System and method for adjusting insulin delivery

• US 10,758,675 B2
• Filed: 01/12/2018
• Issued: 09/01/2020
• Est. Priority Date: 01/13/2017
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: Bigfoot Biomedical, Inc.
• Inventors: Mazlish, Bryan, Desborough, Lane, Naylor, Ross
• Primary Examiner(s): Mendez, Manuel A
• Application Number:
  US15/870,646
• Publication Number:
  US 20180200436A1
• Time in Patent Office: 963 Days
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/1586 Holding accessories for holding infusion needles on the body holding devices for catheters A61M25/02
• CPC Class Codes: A61M 2205/3313 used specific wavelengths
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

The embodiments described herein may relate to methods and systems for adjusting insulin delivery. Some methods and systems may be configured to adjust insulin delivery to personalize automated insulin delivery for a person with diabetes. Such personalization may include receiving and/or determining one or more user specific dosage parameters.

Claims

1. A method of delivering insulin, the method comprising:

receiving at least a daily basal rate (BR) for a user and at least one of a carbohydrate-to-insulin ratio (CR) and an insulin sensitivity factor (ISF) for the user;

determining a first relationship between the BR and at least one of the CR and the ISF for the user;

comparing the first relationship with a probability distribution of a second relationship between a general BR, a general CR, and a general ISF; and

based on the first relationship exceeding a threshold distance from the probability distribution, generating, at a user interface, an indication that the first relationship exceeds the threshold distance and providing a recommended variation in at least one of CR and ISF.

2. The method of claim 1, wherein generating the indication includes generating a visual depiction of the probability distribution of the general CR and general ISF for the BR of the user and an indicator of a location of the first relationship along the visual depiction.

3. The method of claim 1, wherein generating the indication includes generating a plurality of curves illustrating the general BR relative to at least one of the general CR and the general ISF and an indicator of a location relative to the plurality of curves for at least one of the CR and the ISF for the user.

4. The method of claim 1, wherein if the CR for the user is not received, the method further comprising determining the CR for the user based on the BR for the user according to CR=a*BR−

b where a is a number between approximately 114 and 126, and b is a number between approximately 0.785 and 0.815.

5. The method of claim 1, wherein if the ISF for the user is not received, the method further comprising determining the ISF for the user based on the BR for the user according to ISF=x*BR−

y where x is a number between approximately 1115 and 1140, and y is a number between approximately 1.00 and 1.06.

6. The method of claim 5, wherein comparing the first relationship with a probability distribution of a relationship between a general BR, a general CR, and a general ISF comprises determining a probability that the first relationship falls outside the probability distribution, the probability distribution following a multivariate normal distribution with mean μ

and covariation matrix Σ and

a distance D_m of the first relationship (X) from the probability distribution Dm=x−

μ

TΣ

−

1(x−

μ

), the probability that the first relationship falls outside the probability distribution determined by P(x+μ

Σ

≤

Dm)=γ

(32,Dm22)Γ

(32) where □

is a lower incomplete Gamma function and Γ

is a Gamma function.

7. The method of claim 6, wherein the mean μ

is approximately μ

=3.01112.37573.8645 and the covariation matrix Σ

is approximately Σ

=0.2843−

0.1657−

0.2216−

0.16570.19780.1863−

0.22160.18630.2968.

8. The method of claim 6, wherein a magnitude of the probability that the first relationship falls outside the probability distribution is depicted by one of color or a numerical score.

9. A method of delivering insulin, the method comprising:

receiving at least a daily basal rate (BR) for a user;

determining a carbohydrate-to-insulin ratio (CR) based on the BR for the user;

calculating a bolus dose of insulin to account for food to be ingested by the user based on the CR;

generating a message to an electronic insulin delivery device to deliver the bolus dose of insulin; and

delivering the bolus dose of insulin.

10. The method of claim 9, wherein determining the CR is performed according to CR=a*BR−

b where a is a number between approximately 114 and 126, and b is a number between approximately 0.785 and 0.815.

11. A method of delivering insulin, the method comprising:

receiving at least a daily basal rate (BR) for a user;

determining an insulin sensitivity factor (ISF) based on the BR for the user;

calculating a bolus dose of insulin based on the ISF, the bolus dose of insulin to account for a blood glucose reading beyond a threshold variation from a target blood glucose level;

generating a message to an electronic insulin delivery device to deliver the bolus dose of insulin; and

delivering the bolus dose of insulin.

12. The method of claim 11, wherein determining the ISF is performed according to ISF=x*BR−

y where x is a number between approximately 1115 and 1140, and y is a number between approximately 1.00 and 1.06.